Clinical trial

A Phase II Multicenter, Single Arm Study of Oral BGJ398 in Adult Patients With Advanced or Metastatic Cholangiocarcinoma With FGFR2 Gene Fusions or Other FGFR Genetic Alterations Who Failed or Are Intolerant to Platinum-based Chemotherapy

Name

CBGJ398X2204

Description

This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic alterations.

Trial arms

Trial start

2014-07-23

Estimated PCD

2021-03-01

Trial end

2022-02-07

Status

Terminated

Phase

Early phase I

Treatment

BGJ398 (infigratinib)

Capsule for oral use

Arms:

BGJ398 (infigratinib)

Size

143

Primary endpoint

Overall Response Rate (ORR) as Assessed by Blinded Independent Central Imaging Review (BICR)

Analysis was conducted when all subjects in Cohort 1 had the opportunity to be followed for at least 10 months after their initial exposure to infigratinib. Data cutoff 01 March 2021.

Eligibility criteria

Inclusion criteria: - Adult patients with histologically or cytologically confirmed cholangiocarcinoma at the time of diagnosis. Patients with cancers of the gallbladder or ampulla of Vater are not eligible. - Patients must have received at least one prior regimen containing gemcitabine with or without cisplatin for advanced/ metastatic disease. Patient should have evidence of progressive disease following prior regimen, or if prior treatment discontinued due to toxicity must have continued evidence of measurable or evaluable disease. Exclusion criteria: * Prior or current treatment with a MEK inhibitor (all Cohorts), BGJ398 (infigratinib) (all Cohorts), or selective FGFR inhibitor (Cohorts 1 and 2 only). * insufficient organ function * Absolute Neutrophil Count (ANC) \< 1,000/mm3 \[1.0 x 10\^9/L\] * Platelets \< 75,000/mm3 \[75 x 10\^9/L\] * Hemoglobin \< 109.0 g/dL * Total bilirubin \> 1.5x upper limit of normal (ULN) * Aspartate aminotransferase/glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/glutamic pyruvic transaminase (ALT/SGPT) \> 2.5x ULN (AST and ALT \> 5x ULN in the presence of liver metastases) * Serum creatinine \> 1.5x ULN and a calculated or measured creatinine clearance \< 45 mL/min * Inorganic phosphorus outside of normal limits * Total and ionized serum calcium outside of normal limits Other protocol-defined inclusion/exclusion criteria may apply.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 143, 'type': 'ACTUAL'}}

Updated at

2023-07-03

1 organization

1 product

2 indications

Organization

Product

Indication

Indication